Senior Director/Director, Downstream Process Development
Senior Director/Director, Downstream Process Development
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.
Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:
The Senior Director/Director, Downstream Process Development will be a key member of the Technical Operations Leadership Team and will be responsible for all activities related to Downstream Process Development of our late-stage clinical biologics (Mab) molecule AK002 and early stage programs. This position leads the Purification Group which is responsible for the process development, tech transfer, supervision of engineering and clinical batches, process characterization, and BLA enabling activities, including authoring and review.
Your Role:
- Provide technical and managerial leadership to the Downstream Process Development group
- Accountable for all activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate effectively to management
- Coordinate with Upstream development, Analytical and Manufacturing departments to successfully complete the DSP activities
- Provide the overall strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results and review reports for studies.
- Plan the downstream process development experiments for new molecules and supervise execution of the same.
- Supervise the engineering and early clinical batches at CMOs, Review and approve bill of Materials, bill of Parameters, and support deviations and CAPA documents for these batches
- Partner with Manufacturing to review and approve protocols and reports for PPQ batches
- Author and review BLA documents
- Lead cross functional meetings with Quality, Regulatory, Supply Chain, Process Development, Analytical and Drug Product to build consensus on key issues and facilitate decision-making to move the project forward
- Travel domestically and internationally up to 10% of the time
Qualifications and Expertise:
- At least 15 years of relevant experience (12+ with MS, 10+ for PhD) successfully working in biopharmaceutical industry with proven track record of leadership and success
- At least 8 years managing cross functional projects and leading teams
- Extensive experience in Downstream process development and process characterization of biologics molecules such as mAbs and bispecifics.
- Experience in technology transfer and facility fit assessments
- Experience in process development for early and late stage biologics, process characterization, PPQ batches and other BLA enabling studies.
- Experience working with Contract Manufacturers is preferred.
- Experienced in BLA submissions.
- Experience in people and stakeholder management, conflict resolution, and building consensus.
- Good understanding of cGMP-regulations including relevant US/EU regulatory and quality requirements, practices, and standards.
- Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.
- Ability to travel at least 10% of the time.
The salary is competitive and commensurate with experience and qualifications.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.